usda-fsis agency report fsis agency report 2012 fall

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USDA USDA - - FSIS Agency Report FSIS Agency Report 2012 Fall Executive Board Meeting 2012 Fall Executive Board Meeting Conference for Food Protection Conference for Food Protection John M. Hicks, Jr., DVM, MPH Office of Policy and Program Development Food Safety Inspection Service U.S. Department of Agriculture 1 1

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Page 1: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

USDAUSDA--FSIS Agency ReportFSIS Agency Report 2012 Fall Executive Board Meeting2012 Fall Executive Board Meeting

Conference for Food ProtectionConference for Food Protection

John M. Hicks, Jr., DVM, MPHOffice of Policy and Program Development

Food Safety Inspection ServiceU.S. Department of Agriculture

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Page 2: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Organizational ChangesOrganizational Changes

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Page 3: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Office of Field Operations (OFO)Office of Field Operations (OFO)Dr. Daniel L. Engeljohn, Assistant AdministratorDr. Daniel L. Engeljohn, Assistant Administrator

Formerly Assistant Administrator of the Office of Policy and ProFormerly Assistant Administrator of the Office of Policy and Program gram DevelopmentDevelopment

Office of Policy and Program Development Office of Policy and Program Development (OPPD)(OPPD)Rachel Edelstein, Acting Assistant AdministratorRachel Edelstein, Acting Assistant Administrator

Formerly Deputy Assistant Administrator of the Office of Formerly Deputy Assistant Administrator of the Office of Policy and Program DevelopmentPolicy and Program Development

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Page 4: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Update on LabelingUpdate on Labeling

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Page 5: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Nutrition Labeling of SingleNutrition Labeling of Single--Ingredient Ingredient and Ground or Chopped Productsand Ground or Chopped Products

Major CutsMajor Cuts: The final rule requires nutrition labeling : The final rule requires nutrition labeling of the major cuts of singleof the major cuts of single--ingredient, raw meat and ingredient, raw meat and poultry products poultry products 11, unless an exemption applies. , unless an exemption applies. Nutrition information for these products will be Nutrition information for these products will be required either on their label or at their pointrequired either on their label or at their point--ofof--purchase (e.g., by sign or brochure).purchase (e.g., by sign or brochure).

Ground or Chopped ProductsGround or Chopped Products: The final rule requires : The final rule requires nutrition labels on all ground or chopped meat and nutrition labels on all ground or chopped meat and poultry products, with or without added seasonings, poultry products, with or without added seasonings, unless an exemption applies.unless an exemption applies.

1 The major cuts are identified in Sections 317.344 and 381.444.1 The major cuts are identified in Sections 317.344 and 381.444. 55

Page 6: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

NonNon--Major CutsMajor Cuts

The final rule does not require nutrition information for The final rule does not require nutrition information for singlesingle--ingredient, raw meat and poultry products that are ingredient, raw meat and poultry products that are not not major cuts and that are not ground or chopped (e.g., major cuts and that are not ground or chopped (e.g., whole duck not subject; ground duck would be subject)whole duck not subject; ground duck would be subject)

But, if nutrition information is provided for these products, But, if nutrition information is provided for these products, it must be provided in accordance with the nutrition it must be provided in accordance with the nutrition information labeling requirements for the major cutsinformation labeling requirements for the major cuts

Examples of nonExamples of non--major cuts are beef flank steak, beef major cuts are beef flank steak, beef ribs, and chicken tendersribs, and chicken tenders

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Page 7: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

ImplementationImplementation

Implementation of the final rule became effective on Implementation of the final rule became effective on March 1, 2012March 1, 2012

Nutrition labeling materials are on FSIS website Nutrition labeling materials are on FSIS website http://www.fsis.usda.gov/Regulations_&_Policies/Nutrition_Labelihttp://www.fsis.usda.gov/Regulations_&_Policies/Nutrition_Labeling/content_ng/content_Nutrition_Labeling.asp#Nutrition_ChartNutrition_Labeling.asp#Nutrition_Chart

FSIS issued Notice 15FSIS issued Notice 15--12 for verification activities 12 for verification activities http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/15http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/15--12.pdf12.pdf

IPP are not to retain ground or chopped meat or poultry IPP are not to retain ground or chopped meat or poultry products, or take any other regulatory control action or products, or take any other regulatory control action or withholding action, because the products do not have withholding action, because the products do not have ““Nutrition FactsNutrition Facts”” labelslabels

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Page 8: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Revised Jerky GuidelineRevised Jerky Guideline

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Page 9: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Revised Jerky GuidelineRevised Jerky Guideline

FSIS Notice 46FSIS Notice 46--12, Notification of 12, Notification of Availability of Revised Jerky GuidelineAvailability of Revised Jerky Guideline

This notice, issued on 7/25/12, informs inspection This notice, issued on 7/25/12, informs inspection program personnel (IPP) that a revised program personnel (IPP) that a revised FSIS Compliance FSIS Compliance Guideline for Meat and Poultry Jerky Produced by Small Guideline for Meat and Poultry Jerky Produced by Small and Very Small Plantsand Very Small Plants is available.is available.

This notice also informs Enforcement, Investigations, This notice also informs Enforcement, Investigations, and Analysis Officers (EIAOs) that they are to review the and Analysis Officers (EIAOs) that they are to review the information in the compliance guideline as part of their information in the compliance guideline as part of their preparation for conducting food safety assessments preparation for conducting food safety assessments (FSAs) in establishments that produce jerky products (FSAs) in establishments that produce jerky products

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Page 10: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Revised Jerky GuidelineRevised Jerky GuidelineThe revised compliance guideline replaces the previous versions The revised compliance guideline replaces the previous versions which was last updated in 2007. which was last updated in 2007.

There have been a number of journal articles that have been There have been a number of journal articles that have been published since 2003 that have increased the scientific published since 2003 that have increased the scientific understanding of the critical factors during jerky processing understanding of the critical factors during jerky processing including the role of humidity. including the role of humidity.

The revised compliance guideline reflects the most upThe revised compliance guideline reflects the most up--toto--date date science and understanding of jerky processing as well as lessonsscience and understanding of jerky processing as well as lessonslearned through recent FSAs. learned through recent FSAs.

In particular, the revised guideline provides more flexible optiIn particular, the revised guideline provides more flexible options ons with respect to humidity and other processing steps to ensure thwith respect to humidity and other processing steps to ensure the e safety of jerky products. safety of jerky products.

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Page 11: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

RecallsRecalls

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Page 12: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Requirements for Official Requirements for Official Establishments To Notify FSIS of Establishments To Notify FSIS of

Adulterated or Misbranded Product, Adulterated or Misbranded Product, Prepare and Maintain Written Recall Prepare and Maintain Written Recall Procedures, and Document Certain Procedures, and Document Certain Hazard Analysis and Critical Control Hazard Analysis and Critical Control Points System Plan Reassessments Points System Plan Reassessments

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Page 13: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Implementing provisions of the Food, Conservation, Implementing provisions of the Food, Conservation, and Energy Act of 2008 by amending the Federal and Energy Act of 2008 by amending the Federal meat and poultry products inspection regulationsmeat and poultry products inspection regulations

Under this final rule, implemented on May 8, 2012, Under this final rule, implemented on May 8, 2012, FSIS is requiring official establishments to:FSIS is requiring official establishments to:

Promptly notify the appropriate District Office that an Promptly notify the appropriate District Office that an adulterated or misbranded meat or poultry product has adulterated or misbranded meat or poultry product has entered commerce;entered commerce;

FSIS requires that official establishments notify the appropriatFSIS requires that official establishments notify the appropriate District e District Office that an adulterated or misbranded product received by or Office that an adulterated or misbranded product received by or originating from the establishment has entered commerce, if the originating from the establishment has entered commerce, if the establishment believes or has reason to believe that this has haestablishment believes or has reason to believe that this has happened. ppened. FSIS is requiring that this notification occur as quickly as posFSIS is requiring that this notification occur as quickly as possible, but sible, but within 24 hours of the establishment learning or determining thawithin 24 hours of the establishment learning or determining that an t an adulterated or misbranded product received by or originating froadulterated or misbranded product received by or originating from it m it has entered commerce.has entered commerce.

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Implementing provisions of the Food, Conservation, Implementing provisions of the Food, Conservation, and Energy Act of 2008 by amending the Federal and Energy Act of 2008 by amending the Federal meat and poultry products inspection regulationsmeat and poultry products inspection regulations

Require official establishments to prepare and Require official establishments to prepare and maintain written procedures for the recall of all meat maintain written procedures for the recall of all meat and poultry products produced and shipped by the and poultry products produced and shipped by the establishment establishment

FSIS is requiring that establishments prepare and maintain FSIS is requiring that establishments prepare and maintain written procedures for the recall of meat and poultry written procedures for the recall of meat and poultry products produced and shipped by the establishment for use products produced and shipped by the establishment for use should it become necessary for the establishment to remove should it become necessary for the establishment to remove product from commerce. product from commerce. These written recall procedures have to specify how the These written recall procedures have to specify how the establishment will decide whether to conduct a product establishment will decide whether to conduct a product recall and how the establishment will effect the recall, recall and how the establishment will effect the recall, should it decide that one is necessary.should it decide that one is necessary.

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Page 15: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Implementing provisions of the Food, Conservation, Implementing provisions of the Food, Conservation, and Energy Act of 2008 by amending the Federal and Energy Act of 2008 by amending the Federal meat and poultry products inspection regulationsmeat and poultry products inspection regulations

Require official establishments to document each Require official establishments to document each reassessment of the establishment's Hazard Analysis reassessment of the establishment's Hazard Analysis and Critical Control Point (HACCP) plans. and Critical Control Point (HACCP) plans.

FSIS requires establishments to reassess their HACCP plans FSIS requires establishments to reassess their HACCP plans annually and whenever any changes occur that could affect the annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Under this rule, hazard analysis or alter the HACCP plan. Under this rule, establishments must document each reassessment, the reasons establishments must document each reassessment, the reasons for any changes to the HACCP plan, or the reasons for not for any changes to the HACCP plan, or the reasons for not changing the HACCP plan. changing the HACCP plan. For annual reassessments, if the establishment determines that For annual reassessments, if the establishment determines that no changes are necessary, documentation of this determination no changes are necessary, documentation of this determination is not necessary. The recall procedures and reassessment is not necessary. The recall procedures and reassessment documentation will have to be made available for official reviewdocumentation will have to be made available for official reviewand copying. and copying. 1515

Page 16: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Notice 34Notice 34--1212

RESPONSIBILITIES RELATED TO RECEIVING NOTICE OF ADULTERATED OR MISBRANDED PRODUCT, AND VERIFYING WRITTEN RECALL PROCEDURES AND HACCP REASSESSMENT DOCUMENTATION

The notice instructs inspection program personnel (IPP) to make The notice instructs inspection program personnel (IPP) to make establishments aware of the requirements of the final rule and establishments aware of the requirements of the final rule and where to find information about the final rule. where to find information about the final rule.

This notice instructs District Office (DO) personnel on how to This notice instructs District Office (DO) personnel on how to respond when an official establishment notifies them that respond when an official establishment notifies them that adulterated or misbranded product has entered commerce, as adulterated or misbranded product has entered commerce, as required under the final rule. required under the final rule.

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Notice 34Notice 34--1212This notice also provides instruction on how to verify that an oThis notice also provides instruction on how to verify that an official fficial establishment is documenting its HACCP reassessments, as requireestablishment is documenting its HACCP reassessments, as required d by the final rule. by the final rule.

The requirements concerning written recall procedures have delayThe requirements concerning written recall procedures have delayed ed applicability dates based on establishment size. applicability dates based on establishment size. 1. Existing large establishments, defined as all establishments 1. Existing large establishments, defined as all establishments with 500 or with 500 or

more employees, are to prepare their written recall procedures bmore employees, are to prepare their written recall procedures by y November 5, 2012. November 5, 2012.

2. Existing small establishments, defined as all establishments 2. Existing small establishments, defined as all establishments with 10 or with 10 or more employees but fewer than 500, are to prepare their written more employees but fewer than 500, are to prepare their written recall recall procedures by May 8, 2013. procedures by May 8, 2013.

3. Existing very small establishments, defined as all establishm3. Existing very small establishments, defined as all establishments with ents with fewer than 10 employees or annual sales of less than $2.5 milliofewer than 10 employees or annual sales of less than $2.5 million, are n, are to prepare their written recall procedures by May 8, 2013. to prepare their written recall procedures by May 8, 2013.

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Page 18: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Changes to FSIS Traceback, Recall Procedures for Changes to FSIS Traceback, Recall Procedures for E. E. colicoli O157:H7 Positive Raw Beef Product, and O157:H7 Positive Raw Beef Product, and

Availability of Compliance Guidelines Availability of Compliance Guidelines

In this notice, published May 7, 2012, FSIS is In this notice, published May 7, 2012, FSIS is announcing proposed new procedures that it intends to announcing proposed new procedures that it intends to implement when FSIS or other Federal or State agencies implement when FSIS or other Federal or State agencies find raw ground beef presumptive positive for find raw ground beef presumptive positive for E. coliE. coliO157:H7. O157:H7.

This methodology will enable FSIS to better determineThis methodology will enable FSIS to better determinewhether the establishments that produced the source whether the establishments that produced the source materials for contaminated product have produced other materials for contaminated product have produced other product that may not be microbiologically independent product that may not be microbiologically independent from the contaminated product.from the contaminated product.

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Changes to FSIS Traceback, Recall Procedures for Changes to FSIS Traceback, Recall Procedures for E. E. colicoli O157:H7 Positive Raw Beef Product, and O157:H7 Positive Raw Beef Product, and

Availability of Compliance Guidelines Availability of Compliance Guidelines

The Agency is also announcing its intention to now, as a The Agency is also announcing its intention to now, as a matter of routine policy, request a recall if:matter of routine policy, request a recall if:

An establishment was the sole supplier of beef trim source materAn establishment was the sole supplier of beef trim source materials ials for ground product that FSIS or other Federal or State agencies for ground product that FSIS or other Federal or State agencies find find positive for positive for E. coli E. coli O157:H7,O157:H7,

Evidence suggests that contamination most likely occurred at theEvidence suggests that contamination most likely occurred at thesupplier establishment, andsupplier establishment, and

A portion of the product from the originating source lot was senA portion of the product from the originating source lot was sent to t to other establishmentsother establishments. .

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Page 20: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Changes to FSIS Traceback, Recall Procedures for Changes to FSIS Traceback, Recall Procedures for E. E. coli coli O157:H7 Positive Raw Beef Product, and O157:H7 Positive Raw Beef Product, and

Availability of Compliance Guidelines Availability of Compliance Guidelines

This notice also explains that FSIS intends to This notice also explains that FSIS intends to determine whether it can make better use of determine whether it can make better use of establishment results and also intends to conduct establishment results and also intends to conduct a study to help it identify the source of a study to help it identify the source of E. coli E. coli O157:H7 positive ground beef when the material O157:H7 positive ground beef when the material from multiple suppliers was used to produce from multiple suppliers was used to produce positive product. positive product.

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Page 21: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Changes to FSIS Traceback, Recall Procedures for Changes to FSIS Traceback, Recall Procedures for E. E. colicoli O157:H7 Positive Raw Beef Product, and O157:H7 Positive Raw Beef Product, and

Availability of Compliance Guidelines Availability of Compliance Guidelines This notice also announces the availability of complianceThis notice also announces the availability of complianceguidelines concerning establishment sampling and testing guidelines concerning establishment sampling and testing for shiga toxinfor shiga toxin--producing producing E. coli E. coli (STEC) organisms or (STEC) organisms or virulence markers and compliance guidelines for virulence markers and compliance guidelines for E. coli E. coli O157:H7 sampled and tested labeling claims.O157:H7 sampled and tested labeling claims.

Compliance Guideline for Compliance Guideline for E. coliE. coli O157:H7 Sampled and O157:H7 Sampled and Tested Claims for Boneless Beef Manufacturing Tested Claims for Boneless Beef Manufacturing Trimmings (Trimmings (““TrimTrim””))

Compliance Guideline for Establishments Sampled Beef Compliance Guideline for Establishments Sampled Beef Trimmings for Shiga ToxinTrimmings for Shiga Toxin--producing producing E. coliE. coli (STEC) (STEC) Organisms or Virulence MarkersOrganisms or Virulence Markers

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Page 22: USDA-FSIS Agency Report FSIS Agency Report 2012 Fall

Recent Multistate Recent Multistate SalmonellaSalmonella Enteritidis Enteritidis Outbreak InvestigationOutbreak Investigation

Example of recent outbreak investigation, traceback of Example of recent outbreak investigation, traceback of contaminated beef to the producing facility involving contaminated beef to the producing facility involving inadequate recordkeeping at retail establishments that inadequate recordkeeping at retail establishments that grind beef productsgrind beef products

During a previous During a previous SalmonellaSalmonella Typhimurium investigation, a retail Typhimurium investigation, a retail store did not keep grinding logs and only cleaned their grindersstore did not keep grinding logs and only cleaned their grindersonce per day. As a result, multiple suppliers of ground beef weronce per day. As a result, multiple suppliers of ground beef were e identified by the of Program Evaluation, Enforcement & Review identified by the of Program Evaluation, Enforcement & Review (OPEER) during the traceback. (OPEER) during the traceback.

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Recent Multistate Recent Multistate SalmonellaSalmonella Enteritidis Enteritidis Outbreak InvestigationOutbreak Investigation

A recent multistateA recent multistate SalmonellaSalmonella Enteritidis outbreak occurred Enteritidis outbreak occurred associated with ground beef product from the same retail store. associated with ground beef product from the same retail store. The The outbreak involved 46 caseoutbreak involved 46 case--patients from 9 states.patients from 9 states.

During this recent During this recent SalmonellaSalmonella Enteritidis investigation, the retail Enteritidis investigation, the retail store cleaned and sanitized the grinders after the store trim wastore cleaned and sanitized the grinders after the store trim was s ground to produce the 80% ground beef product. ground to produce the 80% ground beef product.

The trim was derived from ~ 8 different FSISThe trim was derived from ~ 8 different FSIS--regulated regulated establishments. The 80% product was produced first thing in the establishments. The 80% product was produced first thing in the morning. Thereafter, tube meat was used to produce 73%, 85%, morning. Thereafter, tube meat was used to produce 73%, 85%, and 90% ground beef. During the investigation, 85% was the most and 90% ground beef. During the investigation, 85% was the most common lean ratio purchased and consumed by casecommon lean ratio purchased and consumed by case--patients. patients.

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